MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ICAST COVERED STENT

Model Number 85424

Device Problem Deflation Problem (1149)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2014

Event Type  Injury  

Event Description

Report was received that a stent was deployed.The balloon was deflated and it was attempted to remove the catheter from a terumo glidewire advantage.035" out of a 7fr 10cm terumo pinnacle sheath.The physician and the tech experienced resistance backing the catheter off but they continued to pull out the catheter.The balloon broke off into the sheat and the physician had to get a second access in the patient to continue the procedure.

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.

• Brand Name: ICAST COVERED STENT
• Type of Device: COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH
• Manufacturer Contact: lori gosselin, sr. qa spec ; 5 wentworth drive; hudson, NH 03051 ; 6038801433
• MDR Report Key: 3894006
• MDR Text Key: 4424558
• Report Number: 1219977-2014-00179
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: 85424
• Device Catalogue Number: 85424
• Device Lot Number: 206923
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2014
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BOSTON SCIENTIFIC XXL DILATION BALLOON - 14MM; TERUMO GLIDEWIRE ADVANTAGE - 0.035 X 260CM; TERUMO INTRODUCER SHEATH - 7FR X 10CM
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 86